Events

Recall of Tina-quant Albumin. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-01103-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-11-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01103-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Roche diagnostics is recalling one lot of tina-quant albumin (used for the determination of specific proteins in samples) following advice that it may show an elevated qc recovery outside of specification when used on the modular p analyser.This phenomenon is only noted when using roche qc precinorm puc (material number 03121313122).
  • Action
    Roche is advising users to inspect stock and discard all units of the affected lot number. Affected stock will be replaced by alternative lots which are unaffected by this issue. This action has been closed-out on 29/08/2016.

Device

Tina-quant Albumin. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Tina-quant Albumin. An in vitro diagnostic medical device (IVD)Material Number: 04999622190Lot Number: 60221401ARTG Number: 174908
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited